Portex 503060Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10351688017772), received between Mar 3, 2020 and Feb 13, 2023 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K934465); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE PAST 3-4 TIMES THE CUFF WOULD NOT INFLATE WHILE TRYING TO INSERT TRACH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16365788 ↗
• InjuryJun 30, 2022Fracture; Fracture

  PREMATURE TRACH CHANGE HAD TO TAKE PLACE. IT WAS REPORTED THAT ONCE THE TRACH WAS INFLATED, IN THE PATIENT, THE TUBE BROKE WHERE IT CONNECTS TO THE BALLOON. IT WAS ORIGINALLY THOUGHT IT WAS NORMAL WEAR AND TEAR. BUT WHEN THE CUSTOMER HAD OTHER DEVICES START TO FAIL, IT WAS THEN REALIZED THERE MIGHT BE AN ISSUE. THERE WAS NO INJURY OR TRAUMA WHEN THE TRACH BROKE OR WHEN THEY WERE REPLACED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 14879602 ↗
• InjuryJun 29, 2022Fracture; Fracture

  PREMATURE TRACH CHANGE HAD TO TAKE PLACE. IT WAS REPORTED THAT ONCE THE TRACH WAS INFLATED, IN THE PATIENT, THE TUBE BROKE WHERE IT CONNECTS TO THE BALLOON. IT WAS ORIGINALLY THOUGHT IT WAS NORMAL WEAR AND TEAR. BUT WHEN THE CUSTOMER HAD OTHER DEVICES START TO FAIL, IT WAS THEN REALIZED THERE MIGHT BE AN ISSUE. THERE WAS NO INJURY OR TRAUMA WHEN THE TRACH BROKE OR WHEN THEY WERE REPLACED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 14859291 ↗
• InjuryJun 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONCE THE TRACH WAS INFLATED THE TUBE BREAKS WHERE IT'S CONNECTED TO THE BALLOON. THERE WAS NO INJURY OR TRAUMA WHEN THE TRACH BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788890 ↗
• InjuryJun 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONCE THE TRACH WAS INFLATED THE TUBE BREAKS WHERE IT'S CONNECTED TO THE BALLOON. THERE WAS NO INJURY OR TRAUMA WHEN THE TRACH BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788868 ↗
• InjuryJun 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONCE THE TRACH WAS INFLATED THE TUBE BREAKS WHERE IT'S CONNECTED TO THE BALLOON. THERE WAS NO INJURY OR TRAUMA WHEN THE TRACH BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788469 ↗
• MalfunctionJun 2, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN CHANGING THE PATIENTS TRACH, THE PILOT BALLOON PORT DID NOT ACCEPT THE SYRINGE. MULTIPLE SIZED SYRINGES WERE USED AND NONE FIT THE PORT. THE APRIL DELIVERY PORTS ARE ALL THE SAME VS THE MARCH DELIVERY OF PORTS. THE MARCH PORTS WERE ABLE TO FIT SYRINGES. WHEN COMPARED, THE PORTS WERE DIFFERENT SIZES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14576969 ↗
• MalfunctionJun 1, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT WHEN CHANGING THE PATIENT'S TRACH, THE CUFF PORT DOES NOT ACCEPT THE SYRINGE. THE CUSTOMER TRIED WITH MULTIPLE SIZE SYRINGES AND NONE FIT IN THE NEW TRACH CUFF PORT FROM AN APRIL DELIVERY. THE TRACH CUFF PORT FROM THE MARCH DELIVERY ACCEPTS THE ALL SYRINGES. WHEN COMPARED SIDE BY SIDE THE CUFF PORTS ARE DIFFERENT SIZES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566097 ↗
• MalfunctionJun 1, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT WHEN CHANGING THE PATIENT'S TRACH, THE CUFF PORT DOES NOT ACCEPT THE SYRINGE. THE CUSTOMER TRIED WITH MULTIPLE SIZE SYRINGES AND NONE FIT IN THE NEW TRACH CUFF PORT FROM AN APRIL DELIVERY. THE TRACH CUFF PORT FROM THE MARCH DELIVERY ACCEPTS THE ALL SYRINGES. WHEN COMPARED SIDE BY SIDE THE CUFF PORTS ARE DIFFERENT SIZES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566093 ↗
• MalfunctionNov 19, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF IS NOT INFLATING ON PORTEX TRACH TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848331 ↗
• MalfunctionNov 19, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF IS NOT INFLATING ON PORTEX TRACH TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12848073 ↗
• MalfunctionNov 19, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF IS NOT INFLATING ON PORTEX TRACH TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847736 ↗
• MalfunctionMar 3, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT ONE WEEK FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX® CUFFED D.I.C® TRACHEOSTOMY TUBE, THE CUFF WAS FOUND LEAKING. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9782176 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K934465. One submission often covers many models, so check the product and lot details in each record.

• Z-0229-05 · Sep 9, 2004 · Terminated
  Portex Lo-Profile Tracheostomy Tube Decannulation Cap Catalog Number: 582000
• Z-0228-05 · Sep 9, 2004 · Terminated
  Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tubes Catalog Number: 519000